Olympus recalls GF-UCT160-OL5 ultrasound endoscopes due to updated cleaning instructions potentially increasing infection risk during patient procedures.
A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
Olympus is recalling ultrasound endoscopes (model GF-UCT160-OL5) because recent changes to cleaning instructions might increase infection risks during medical procedures. This affects healthcare providers using the device for diagnostic imaging.
The recall involves updated cleaning instructions that could theoretically increase infection risks if not followed properly during medical procedures. This is a procedural change to reduce infection risks during device disinfection.
Healthcare providers who use Olympus Ultrasound Endoscopes (model GF-UCT160-OL5) for diagnostic imaging are most at risk. The recall applies to all units sold with this model number.
Check for the model number GF-UCT160-OL5 on the device or its packaging. This ultrasound endoscope is used for diagnostic imaging or fluid flow analysis of the human body.
Verify the model number on the device or packaging to confirm it matches GF-UCT160-OL5.
The recall is due to updated cleaning instructions that could potentially increase infection risks during medical procedures.
The official recall notice does not specify a remedy or action for affected devices.
The recall focuses on infection risks from cleaning procedures, not physical injury risks.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0506-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0506-2021 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
